Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 99 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: The Effect of Zinc Supplementation Prior to Botulinum Neurotoxin Type A Injection in the Treatment of Spasmodic Dysphonia

Conditions

Spasmodic Dysphonia

Being tested

Zinc gluconate supplement, Botulinum toxin type A

Keywords

zinc, botox, botulinum toxin, spasmodic dysphonia

Medical subject headings

Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Zinc gluconate supplementDrug

  Also called 50 mg zinc gluconate (Puritan's Pride brand)

  Subjects will take a 50 mg zinc gluconate supplement at breakfast for the five days leading up to their next injection appointment. They will also answer questionnaires and provide audio recordings at various time points of the two injection cycles, which is roughly six months.

• Botulinum toxin type ADrug

  Also called Botox Type A

  This is the current standard of care for treatment of spasmodic dysphonia. Botox injection goes into the vocal cord muscle, and will be occur in both the control and experimental arms of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change of Voice-Related Quality of Life (V-RQOL) Survey Scores During a Laryngeal Botox Injection Cycle.

   10 question, validated survey to assess quality of voice of patients with spasmodic dysphonia. The overall V-RQOL score ranges from 10 to 15 (excellent), 16 to 20 (very good), 21 to 25 (good), 26-30 (fair) and scores more than 30 and up to 50 is poor.

   Measured: The patient will submit survey on post-injection day 2, 7, 14, 42, 70 and 98 (if next injection has not been performed).

2. Change in Audiometric Recording Data of Subject's Speech During a Laryngeal Botox Injection Cycle.

   At various points in the study, each subject will be recorded saying the same scripted passage. After all subjects have completed both cycles, all of the accrued audio recordings will be analyzed using a computer algorithm developed by one of our authors that assesses the quality of speech, with the data time points being averaged. The proposed algorithm was not successfully developed. One of the major concerns during the development process was which Natural Language Processing metrics should be utilized to best measure Spasmodic Dysphonia speech changes. No analysis conducted.

   Measured: The patient record their voice on post-injection day 2, 7, 14, 42, 70, and 98. At their next botox injection, a second cycle will immediately begin for an additional 3 months with audio data obtained on post injection day 2, 7, 14, 42, 70, and 98

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted7 Jun 2023
2. Study start1 Aug 2023
3. Primary completion1 Aug 2024
4. Study completion1 Mar 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Spasmodic DysphoniaStudies of the same condition, open and under way.
• More trials run by University of FloridaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.